Cerebral Palsy

Data Standards

The Cerebral Palsy (CP) Common Data Elements (CDE) Working Groups and the National Institute of Neurological Disorders and Stroke (NINDS) CDE Team have released Version 1.0 of the CP CDEs. The NINDS, other Federal agencies, and international organizations have the common mission of developing data standards for clinical research. Through the efforts of subject-specific working groups, topic-driven data elements have been created. The first set of CDEs for Cerebral Palsy was developed in 2015–2016. The Core and Supplemental-Highly Recommended CDEs to be used by an investigator when beginning a research study in this disease/disorder are listed in the Start-up Resource Listing.

Many of the CDEs will overlap across study types, which allows for comparisons and meta-analyses across studies. Consistency of the data elements and the CDE formats are kept in order to ensure the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the NINDS CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing and help educate new clinical investigators.

Organized by working groups (Engagement and Quality of Life Assessments/Data; Health, Growth, Genetics, Comorbidities and Labs; Neurocognitive, Social, and Emotional Assessments; Neuroimaging Diagnostics; Neuromotor Skills and Functional Assessments; and Participant Characteristics and Disease/Injury Related Events), often used in clinical studies, data standards include:

An overview of all Cerebral Palsy CDE recommendations can be found in the Cerebral Palsy CDE Highlight Summary document. For your reference, a zip file containing all the current Cerebral Palsy CDE template CRF modules can be downloaded below.

The outline that follows includes all the CDEs associated with the CRF modules, organized by domain and sub-domain.

Participant Characteristics
Demographics
CRF Module/Guideline CDEs
Demographics CDE Details
General Core CDE Details
Social Status
CRF Module/Guideline CDEs
Social Status CDE Details
Assessments and Examinations
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guideline CDEs
Mutation Analysis CDE Details
Imaging Diagnostics
CRF Module/Guideline CDEs
Neuroimaging Cerebral Palsy Magnetic Resonance Imaging CDE Details
Physical/Neurological Examination
CRF Module/Guideline CDEs
Neurological Examination CDE Details
Physical Examination CDE Details
Vital Signs and Other Body Measures
CRF Module/Guideline CDEs
Vital Signs CDE Details
Outcomes and End Points

Overview

To develop the Cerebral Palsy CDEs, the Cerebral Palsy CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

  • Engagement and Quality of Life Assessments/Data
  • Health, Growth, Genetics, Comorbidities and Labs
  • Neurocognitive, Social, and Emotional Assessments
  • Neuroimaging Diagnostics
  • Neuromotor Skills and Functional Assessments
  • Participant Characteristics and Disease/Injury Related Events

Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines presented are organized into domains which are intuitive and common in clinical research studies.

History and Acknowledgements

The Cerebral Palsy (CP) CDE Working Group was comprised of seven different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The CP CDE Working Group was supported by the NINDS CDE Team. The complete CP CDE Working Group roster and the rosters by Subgroup are shown below:

Complete Cerebral Palsy CDE Roster

Oversight Committee

  • Joline Brandenburg, MD
    Mayo Clinic, Rochester, Minnesota
  • Brian Carlson, PhD
    Ipsen Biopharmaceuticals, Inc., Basking Ridge, New Jersey
  • Diane Damiano, PT, PhD (Until 2018)
    NIH Clinical Center, Bethesda, Maryland
  • Paul Gross
    Cerebral Palsy Research Network, Woodinville, Washington
  • Deborah Gordon Hirtz, MD
    University of Vermont College of Medicine, Burlington, Vermont
  • Sandra E. Juul, MD, PhD
    University of Washington, Seattle, Washington
  • Sarah McIntyre, PhD
    Cerebral Palsy Alliance, University of Sydney, Sydney NSW, Australia
  • Theresa Moulton, PT, PhD
    Northwestern University, Chicago, Illinois
  • Terence Sanger, MD, PhD
    University of Southern California, Los Angeles, California
  • Veronica Schiariti, MD, PhD
    University of British Columbia, Vancouver, British Columbia, Canada
  • Susan Sienko, PhD
    Shriners Hospital for Children, Portland, Oregon
  • Wendy Sullivan
    Reaching for the Stars. A Cerebral Palsy Foundation, Alpharetta, Georgia

AACPDM CDE Steering Committee

  • Eileen Fowler, PT, PhD
    University of California Los Angeles, Los Angeles, California
    Co-Chair
  • Richard D. Stevenson, MD
    University of Virginia, Charlottesville, Virginia
    Co-Chair
  • Diane Damiano, PT, PhD
    NIH Clinical Center, Bethesda, Maryland
  • Laura Prosser, PT, PhD
    Children?s Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Sharon Ramey, PT, PhD
    Virginia Polytechnic Institute, Roanoke, Virginia
  • Jessica Rose, PhD
    Stanford School of Medicine, Stanford, California
  • Elaine Stashinko, PhD, RN
    Kennedy Krieger Institute, Baltimore, Maryland
  • Katherine Steele, PhD
    University of Washington, Seattle, Washington
  • Laura Vogtle, OT, PhD
    University of Alabama at Birmingham, Birmingham, Alabama

Engagement and Quality of Life Assessments/Data

  • Susan Sienko, PhD
    Shriners Hospitals for Children, Portland, Oregon
    Chair
  • Kristie Bjornson, PT, PhD
    Seattle Children?s, Seattle, Washington
  • Stephanie DeLuca, PhD
    Virginia Polytechnic Institute, Blacksburg, Virginia
  • Laura Vogtle, OT, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Margaret Wallen, OT, PhD
    University of Sydney, Sydney, Australia

Health, Growth, Genetics, Co-Morbidities and Labs

  • Theresa Moulton, DPT, PhD
    Northwestern University, Chicago, Illinois
    Chair
  • Kathleen M. Kolaski, MD
    Wake Forest Baptist Health, Winston-Salem, North Carolina
  • Sebastian Schroeder, MD
    Ludwig-Maximilians-University of Munich, Munich, Bavaria, Germany
  • Benjamin J. Shore, MD
    Harvard Medical School, Boston, Massachusetts
  • Richard D. Stevenson, MD
    University of Virginia, Charlottesville, Virginia
  • Gordon Worley, MD
    Duke University School of Medicine, Durham, North Carolina

Intregrated Across Working Groups

  • Veronica Schiariti, MD, PhD
    Children's & Women's Health Centre of British Columbia, Vancouver, British Columbia, Canada
    Chair
  • Sylvia ?unpuu, MSc
    University of Connecticut, Farmington, Connecticut
  • Eileen Fowler, PT, PhD
    University of California Los Angeles, Los Angeles, California
  • Mary Gannotti, PT, PhD
    University of Hartford, Hartford, Connecticut
  • Bernadette Gillick, PT, PhD
    University of Minnesota, Minneapolis, Minnesota

Neurocognitive, Social, and Emotional Assessments/Data

  • Sharon Ramey, PT, PhD
    PhD, Virginia Polytechnic Institute, Roanoke, Virginia
    Chair
  • Rosyln Boyd, PT, PhD
    University of Queensland, Brisbane St Lucia, Australia
  • Michael Msall, MD
    University of Chicago, Chicago, Illinois
  • Seth A. Warschausky, PhD
    University of Michigan, Ann Arbor, Michigan
  • Kathi Zebracki, PhD
    Loyola University Chicago, Chicago, Illinois

Neuroimaging Diagnostics Neuroimaging Diagnostics

  • Eric Levey, MD
    Kennedy Krieger Institute, Baltimore, Maryland
    Chair
  • Patrick Barnes, MD
    Stanford University, Palo Alto, California
  • Rosyln Boyd, PT, PhD
    University of Queensland, Brisbane St Lucia, Australia
  • Hannah Glass, MD
    University of California San Francisco, San Francisco, California
  • Andrea Poretti, MD
    Johns Hopkins University, Baltimore, Maryland
  • Jessica Rose, PhD
    Stanford School of Medicine, Stanford, California

Neuromotor Skill and Functional Assessments

  • Joline Brandenburg, MD
    Mayo Clinic, Rochester, Minnesota
    Chair
  • Michael Aiona, MD
    Shriners Hospitals for Children, Portland, Oregon
  • Mary Jo Cooley Hidecker, PhD MS MA CCC-A/SLP
    University of Wyoming, Laramie, Wyoming
  • Diane Damiano, PT, PhD
    NIH Clinical Center, Bethesda, Maryland
  • Christopher Joseph, MS PT
    Kennedy Krieger Institute, Baltimore, Maryland
  • Claire Morress, OT, PhD
    Cincinnati Children's Perlman Center, Cincinnati, Ohio
  • Laura Prosser, PT, PhD
    Children?s Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Katherine Steele, PhD
    University of Washington, Seattle, Washington

Participant Characteristics and Disease/Injury Related Events

  • Sarah McIntyre, PhD
    University of Sydney, Sydney, Australia
    Chair
  • Katherine Alter, MD
    NIH Clinical Center, Bethesda, Maryland
  • Elaine Stashinko, PhD, RN
    Kennedy Krieger Institute, Baltimore, Maryland
  • Deborah Thorpe, PT, PhD
    University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

NINDS CDE Team

  • James I. Koenig, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    Scientific Program Specialist, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Joanne Odenkirchen, MPH (Until 2016)
    National Institute for Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i, MS (Until 2018)
    The Emmes Corporation
  • Joy Esterlitz, MS
    The Emmes Corporation
  • Robin S. Feldman, BS, MBA
    The Emmes Corporation
  • Katelyn Gay, BS
    The Emmes Corporation
  • Muniza Sheikh, MS, MBA
    The Emmes Corporation

Updates

Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

Cerebral Palsy CDEs Revision History